Argentina - Top Medical Device Alerts

03/21/2023

Applications for renewal of the Certificate of Good Manufacturing Practices for Medical Products ANMAT informs Manufacturers and Importers of Medical Devices and In-vitro Diagnostic Devices, that the GMP Certificate Renewal shall be requested only through the GEMHA system (http://gemha.anmat.gob.ar/login.aspx). If a company has still open processes in other systems, they shall be submitted to the new system.

04/14/2023

Information on receipt, request, and modification of digital and paper certificates ANMAT reminds professionals and companies that the Technical Information Management Department receives the certificates on paper with a holographic (written) signature for attestations of post-registration modifications and the request for a new version of digital certificates (electronic management system) due to modifications post-registration.

12/29/2022

The CLVs of the Republic of Korea will be accepted as equivalent regulations for the registration of medical products As of 2023, this National Administration will accept the certificates of free sale (CLV) issued by the Ministry of Food Safety and Drug Safety of the Republic of Korea (MFDS), as equivalent regulations for the registration of medical products.

11/25/2022

ANMAT launches the Regulatory Assistance Program for Research and Development of Health Products Provision 9281/2022 on the creation of the Regulatory Assistance Program for Research and Development of Health Products was published in the Official Gazette. It will work under the umbrella of the Coordination of Training and Research in Regulatory Science. Its main objective will be to provide regulatory guidance to research and development projects that are of interest to public health.

10/13/2022

Essential Safety and Performance Requirements for Medical Devices and In Vitro Diagnostic Medical Devices It is reported that a new document on Essential Safety and Performance Requirements for medical devices and medical devices for in vitro diagnostics in the area of International Relations has been included in the section on Public Opinion Regulation Projects.

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